The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Max-if1000.
| Device ID | K100246 |
| 510k Number | K100246 |
| Device Name: | MAX-IF1000 |
| Classification | Interferential Current Therapy |
| Applicant | BIO PROTECH, INC. 3010 LBJ FRWY. 12TH FLOOR Dallas, TX 75234 |
| Contact | Judy Burton |
| Correspondent | Judy Burton BIO PROTECH, INC. 3010 LBJ FRWY. 12TH FLOOR Dallas, TX 75234 |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-27 |
| Decision Date | 2010-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817120020573 | K100246 | 000 |
| 00817120020067 | K100246 | 000 |